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Insomnia clinical trials

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NCT ID: NCT01209728 Completed - Insomnia Clinical Trials

Effects of Insomnia on Simulated Driving (MK-0000-183-00)

Start date: October 1, 2010
Phase: Phase 1
Study type: Interventional

This is a double-blind, parallel design study in elderly primary insomnia patients and demographically matched controls. The objectives if this study are primarily: 1. To determine if functional deficits in simulated driving performance can be demonstrated in primary insomnia patients, and detected in healthy volunteers, impaired by alcohol; and secondarily: 2. To compare simulated driving performance deficits in elderly primary insomnia patients to those in healthy elderly volunteers impaired by alcohol, for at least one of the following driving endpoints: standard deviation of lane position (SDLP), standard deviation of speed (speed deviation), lane excursions, and a driving composite score.

NCT ID: NCT01188460 Completed - Chronic Pain Clinical Trials

A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial

Start date: April 2010
Phase: N/A
Study type: Interventional

This study will test the impact of a cognitive-behavioural self-management approach for the management of insomnia among patients with chronic pain. This self-management approach consists of a manual describing cognitive behavioural techniques for the management of insomnia. In terms of primary outcomes, it is anticipated that there would be improvements in sleep-related dimensions such as sleep quality, sleep efficiency, and night-time awakenings in the sample group receiving a copy of the self-help manual intervention to be implemented by participants in their home (intervention group), relative to the group receiving treatment as usual (control group). In terms of secondary outcomes, it is anticipated that the intervention group will show improvements in mood, fatigue, pain severity, and pain-related disability relative to the control group. The tertiary outcome variable of pre-sleep arousal is anticipated to have a moderating or mediating relationship with the sleep variables investigated.

NCT ID: NCT01162655 Completed - Insomnia Clinical Trials

Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth

Start date: April 2010
Phase: N/A
Study type: Interventional

Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants in the Telehealth condition will report significantly greater improvements in sleep parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity, and daytime fatigue than those in the Internet condition and that b)participants in the Telehealth condition will show better adherence to treatment and greater satisfaction with treatment than those in the Internet condition.

NCT ID: NCT01161108 Completed - Epilepsy Clinical Trials

Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of oral melatonin in improving sleep continuity in children with epilepsy and neurodevelopmental delay who have chronic insomnia by comparing Fast Release Melatonin (FR MLT) to placebo and Timed Release Melatonin (TR MLT) with placebo in a randomized cross-over design trial.

NCT ID: NCT01142258 Completed - Alzheimer's Disease Clinical Trials

Trazodone for Sleep Disorders in Alzheimer's Disease

Start date: March 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether trazodone is effective in the treatment of sleep disorders in Alzheimer's disease (AD).

NCT ID: NCT01114126 Completed - Insomnia Clinical Trials

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia

Start date: April 2010
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of Neu-P11, following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching placebo) given nightly over 2 periods of 5 days to male and female subjects with primary insomnia. In addition, the study is aimed to determine the pharmacokinetic profile of Neu-P11 after 1 and 5 days of administration and to evaluate the hypnotic effects of Neu-P11 as well as the effects on mood and memory. The study hypothesis is that Neu-P11 is safe, tolerated and have significant sleep promoting effects.

NCT ID: NCT01106859 Completed - Insomnia Clinical Trials

Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet

Start date: June 2010
Phase: Phase 1
Study type: Interventional

A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid. The next morning driving performance will be measured by taking a standardized driving test.

NCT ID: NCT01105052 Completed - Insomnia Clinical Trials

Self-help Cognitive Behavioral Therapy (CBT) for Insomnia

Start date: February 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether a self-help book for insomnia, with or without therapist support, can improve sleep and alleviate insomnia symptoms in individuals suffering from insomnia, also for persons presenting with different kinds of co-morbid problems.

NCT ID: NCT01100164 Completed - INSOMNIA Clinical Trials

A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia

Eszo
Start date: March 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.

NCT ID: NCT01091987 Completed - Insomnia Clinical Trials

Non-pharmacological Treatment of Insomnia in Nursing Homes.

Start date: April 2010
Phase: N/A
Study type: Interventional

The study wants to examine the feasibility of a non-pharmacological approach for insomnia in nursing homes provided by trained nurses/paramedics and physicians.